510(k) K210500 ยท IYE Accelerator, Linear, Medical
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
| Applicant | Elekta Limited, Crawley, GB |
| Decision | Substantially Equivalent, Jun 11, 2021 |
| Received | Feb 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210500
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2026 | Elekta, Inc. Brand Name: Elekta Medical Linear Accelerator
Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Software Version: N/A
Product Description: Digital Linear Accelerator
Component: N Open, Classified |
IYE | None listed |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | None listed |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | None listed |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | None listed |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | None listed |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | None listed |
| Dec 1, 2023 | Elekta, Inc. ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | None listed |
| May 30, 2023 | Elekta, Inc. Elekta Medical Linear Accelerator (ELMA) included in the below platforms:
a. Elekta Infinity;
b. Versa HD;
c. Elekta Synergy Open, Classified |
IYE | None listed |
| Sep 28, 2021 | ELEKTA SOLUTIONS AB Elekta Medical Linear Accelerator (EMLA):
Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093. Terminated |
IYE | None listed |
| Sep 17, 2021 | Elekta, Inc. Elekta Medical Linear Accelerator (EMLA), configured as follows:
a. Elekta Precise Digital Accelerator;
b. Elekta Harmony;
c. Elekta Synergy;
d. Elekta Infinity;
e. Versa HD Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.